(38 days)
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Not Found
No
The summary describes a simple medical device (tampon) and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device, an organic cotton tampon, is used to absorb menstrual fluid and is not described as providing any therapeutic benefit or treatment for a disease or condition.
No
Explanation: The device, an "Organic Essentials Organically Grown Cotton Tampon," is described as being used to absorb menstrual fluid. This is a functional product for personal hygiene, not a device designed to identify or analyze medical conditions or diseases.
No
The device description clearly states it is a "Organic Cotton Tampon," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to absorb menstrual fluid by insertion into the vagina. This is a physical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: It's described as a tampon, which is a medical device for menstrual hygiene.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue), detecting biomarkers, or providing diagnostic information about a disease or condition.
- No Mention of IVD-Related Terms: The description doesn't include terms commonly associated with IVDs, such as "assay," "reagent," "analyzer," "diagnostic," "screening," etc.
IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This tampon does not fit that description.
N/A
Intended Use / Indications for Use
Organic Essentials Organically Grown Coton Tampon is a tampon that is inserted into the vagina and used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.
Product codes
85 HEB
Device Description
Organic Essentials Organic Cotton Tampon
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vagina
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 1998 NOV
Ms. La Rhea Pepper President Organic Essentials, Inc. 822 Baldridge Street O'Donnell, TX 79351
Re: K983478
Organic Essentials Organic Cotton Tampon Dated: October 1,1998 Received: October 2,1998 Regulatory Class: II 21 CFR 884.5470/Procode: 85 HEB
Dear Ms. Pepper,
We have reviewed your Section 510K) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and . thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1 of
FOA/CDRH/ODE/DMC
13 Ост 53 13 40
510(k) NUMBER (IF KNOWN): K983478
DEVICE NAME: Organic Essentials
INDICATIONS FOR USE: Organic Cotton Tampon
Organic Essentials Organically
XGrown Coton Tampon is a tampon
that is inserted into the vagina and
used to absorb menstrual
fluid.
The intended use of the organic
cotton tampon is the same as
all other products that are
legally marketed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation
Liliau Yi
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
Division of Reploadictive, Abdoming, ENThe - Counter and Radiological Dev (Optional Forma (k) Number
DK-55